cobas¿ HIV1 Quantitative nucleic acid test for use on the cobas¿ 68 88 Systems 06998836190

GUDID 00875197004717

Roche Diagnostics GmbH

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197004717
NIH Device Record Key72c31558-a4fd-4390-9869-5f83f76990df
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas¿ HIV1 Quantitative nucleic acid test for use on the cobas¿ 68 88 Systems
Version Model Number06998836190
Catalog Number06998836190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197004717 [Primary]

FDA Product Code

MKTHepatitis Viral B DNA Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-02-26

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